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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00383058 |
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Date of registration:
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29/09/2006 |
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Primary sponsor: |
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Public title:
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The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
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Scientific title:
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The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00383058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chung-Hua Hsu, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chinese Medicine Dep, Taipei Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 16-60 years old female
2. BMI>27?/m2
3. Signed informed consent
Exclusion Criteria:
1. Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
2. Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient
with pacemaker.
3. Allergy and Immunology disease.
4. High aminotransferases ( Alanine, Aspartate >80 IU/L) or high serum Creatinine (>2.5
mg/dL)
5. Pregnant or lactating women.
6. Childbirth within 6 months.
7. Stroke or otherwise unable to exercise
8. Management for weight control within 3 months.
9. Any other conditions deemed unsuitable for trial as evaluated by the
physician-in-charge.
Age minimum:
16 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Drug: the extract of green tea
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Primary Outcome(s)
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(Percent) reduction of body mass index and body weight
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Secondary Outcome(s)
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(Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride
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leptin, adiponectin and ghrelin comparisons and analysis
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Secondary ID(s)
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NSC-95-2320-B-192-001
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TH-Greentea-06-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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